A Global Imatinib and Nilotinib Pregnancy Exposure Registry
Completed
- Conditions
- All Indications for Glivec/Gleevec and Tasigna
- Interventions
- Registration Number
- NCT01289054
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This is a voluntary, international, primarily prospective, observational, exposure-registry and follow-up study of women receiving Imatinib and Nilotinib during pregnancy or within six months prior to pregnancy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 4
Inclusion Criteria
- Provide sufficient evidence to confirm that exposure occurred during pregnancy or within 6 months prior to exposure.
- Be at least 18 years of age
- Reside in a country supported by the Registry
Exclusion Criteria
- Cases that do not meet the eligibility criteria are deemed ineligible, including paternal exposures
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 - Pregnancy/Fetal Exposure Tasigna - Cohort 1 - Pregnancy/Fetal Exposure Gleevec -
- Primary Outcome Measures
Name Time Method Monitor pregnancies exposed to Imatinib or Nilotinib to estimate prevalence of birth defects During pregnancy or within 6 months prior to conception
- Secondary Outcome Measures
Name Time Method Assess impact on maternal CML disease when treatment is interrupted During pregnancy or within 6 months prior to conception Assess post 12 month post-delivery data on maternal and infant status 12 months after birth
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Imatinib and Nilotinib's effects on fetal development in BCR-ABL-positive pregnancies?
How does Nilotinib compare to Imatinib in managing adverse events during pregnancy for CML/GIST patients?
Which biomarkers correlate with maternal or fetal outcomes in pregnancies exposed to Novartis tyrosine kinase inhibitors?
What are the long-term safety profiles of first-trimester exposure to Imatinib or Nilotinib in the NCT01289054 registry?
Are there combination therapies with Imatinib or Nilotinib that enhance efficacy while minimizing pregnancy-related risks in CML/GIST?
Trial Locations
- Locations (1)
INC Research, LLC
🇺🇸Wilmington, North Carolina, United States